MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number	24657
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed.A 7x150, 130cm eluvia drug-eluting vascular stent system was selected to cover a dissection in the right superficial femoral artery (sfa).Prior to use, angioplasty and atherectomy was performed in the sfa.The eluvia was then inserted and crossed easily.The thumbwheel was used to deploy the stent, but it sounded louder than normal.An attempt was made to deploy using the blue handle, but the blue handle would not engage or move at all; it was stuck.Therefore, the white handle was opened, and the silver covering was manually pulled back over the copper covering.The stent deployed.The procedure was successfully completed.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system.The device was returned with a 0.014 guidewire.Visual examination revealed the rack assembly was broken.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis confirmed the handle rack was broken apart.No stent was returned as it was noted that the stent was deployed manually.
Event or Problem Description
It was reported that the stent partially deployed.A 7x150, 130cm eluvia drug-eluting vascular stent system was selected to cover a dissection in the right superficial femoral artery (sfa).Prior to use, angioplasty and atherectomy was performed in the sfa.The eluvia was then inserted and crossed easily.The thumbwheel was used to deploy the stent, but it sounded louder than normal.An attempt was made to deploy using the blue handle, but the blue handle would not engage or move at all; it was stuck.Therefore, the white handle was opened, and the silver covering was manually pulled back over the copper covering.The stent deployed.The procedure was successfully completed.No patient complications were reported.It was further reported that the stent was approximately 50-60% deployed when the issue occurred.The thumbwheel was used normally until it required greater force and stopped working.The stent was stretched as a result of this event.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19697396
• Report Number: 2124215-2024-41846
• Device Sequence Number: 12551616
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: 08714729876748
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2026
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0033377420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White